Entry-Level Quality Engineer — Medical Device QA

Integer Holdings; Hudson (MA); On-site; USD 64,000 - 93,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Disability and life insurance

401(k) with company match

Paid time off and holidays

Parental leave available

Job summary

Integer is seeking an entry-level Quality Engineer to support a high-volume hydrophobic coating plant. You will collaborate with Manufacturing and QA to ensure product quality while learning Integer's QMS, FDA regulations, and CAPA processes.

You will assist with document control, process validation support, and continuous improvement initiatives, contributing to product quality and regulatory compliance.

Qualifications

• Entry-level engineer role focusing on quality systems and process improvements.
• Strong attention to detail and ability to learn GMP/FDA requirements.
• Effective collaboration with cross-functional teams.
• Commitment to upholding Integer's values and safety standards.

Responsibilities

• Support quality activities of a high-volume hydrophobic coating plant including MRB, CAPA management, complaint investigations, audit support, change management, NPI activities, and continuous improvement.
• Monitor manufacturing to ensure compliance with DMR and provide deviation/waiver guidance; maintain Device History Records.
• Review changes to BOMs, assembly procedures, drawings, specs, FMEAs, control plans; participate in process improvement projects.

Job description

Integer is seeking an entry-level Quality Engineer to support a high-volume hydrophobic coating plant. You will collaborate with Manufacturing and QA to ensure product quality while learning Integer's QMS, FDA regulations, and CAPA processes.

You will assist with document control, process validation support, and continuous improvement initiatives, contributing to product quality and regulatory compliance.